A surgical operation or procedure such as a diagnosis or a medical treatment in which a catheter is used has been popularized because it imposes a comparatively low burden on a patient. Such a surgical operation as just mentioned is performed by introducing various instruments beginning with a catheter into a puncture hole or the like formed in an arm, a leg or another site of the patient and extending to an artery.
In a surgical procedure such as that described above, a wide variety of medical devices and drugs are used, perhaps involving up to several tens of medical devices and drugs, including throwaway unwoven fabrics (drapes) adapted to be spread on an imaging intensifier, devices and drugs such as an antiseptic used at a preparation stage prior to a surgical procedure (such as a set for drip fusion including a needle and a tube for dripping the heparin of an antithrombotic drug to a patient), surgical gowns for doctors, absorbent cottons, tweezers, forceps and scissors for applying antiseptic, skin cutting surgical knives used after a surgical operation is started, indwelling needles, introducer sheaths and dilators, guide wires for the introducer, syringes, angiographic catheters, guide wires for the angiographic catheter, angiographic agent, microcatheters and so forth which are used for a diagnosis or a medical treatment, PTCA (Percutaneous Transluminal Coronary Angioplasty) guiding catheters (shape for the right side of the heart, shape for the left side and so forth), PTCA guide wires, PTCA balloon catheters, balloon dilating devices (indeflators), stent delivery catheters, hemostatic devices used after an operation or procedure, and beakers, cups and so forth for temporarily keeping various drugs and agents. To help prevent infection, most of these medical devices, drugs and the like are of the throwaway type.
Sheath and dilator systems are typically packaged in the same package but separate from each other. The reason for this is that there is a risk of deformation or damage to the valve which limits blood loss during endovascular procedures.
For longer devices this can cause an issue because the package sizes become very long and hard to handle. Additionally, combining the dilator into the sheath can be cumbersome and risk contamination.
For example, during a surgical procedure, long dilators and their corresponding sheaths are removed from sterile packaging by a medical practitioner and are often laid upon the body of the patient as part of preparation for inserting the dilator within the sheath, prior to using them to gain vascular access.
However, due to their length there is risk for the long dilator and the long sheath to come in contact with the floor, or some other non-sterile surface, or become damaged while prepping the dilator, or when combining/inserting the dilator into the sheath. Contact with the operating room floor, or other non-sterile surface, renders both the dilator and the sheath non-sterile and typically requires a replacement device to be used. Prepping another device is both time consuming and costly.
U.S. Pat. No. 7,234,597 teaches a package for an elongate surgical device, such as a catheter, includes an elongate tube formed into a coil configuration with a first coil portion disposed adjacent to a second coil portion. In this package, a thermal weld bonds the coil portions in a fixed relationship and with a strength sufficient to prevent peeling the first coil portion from the second coil portion. The surgical device can then be loaded into the tube, pouched and sterilized for distribution.
Existing devices typically provide for separate sterile packaging for long dilators and long sheaths. However existing devices do not permit sterile insertion of the dilator within the sheath while in shared packaging and do not reduce the possibility of either the dilator or sheath becoming non-sterile by allowing the devices to be combined while still in the package.
In view of the foregoing, there continues to be a need for an elongated surgical device packaging in which elongated surgical devices such as a sheath and dilator, may be packaged separately but secured and oriented in such a coiled configuration that facilitates inserting the dilator into the sheath without removing the sheath from its coil.